Summary

This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table6, Band H.

Duties

Help

• Oversees planning, development, and direction of patient-focused, risk-based strategies to secure safety, efficacy, and quality of cellular, tissue, gene therapy, therapeutic vaccines, plasma-derived/coagulation products, and related devices.
• Advises the Center Director and other officials on the Food and Drug Administration's (FDA) regulatory and enforcement responsibilities and possible risks.
• Implements programs and projects to identify, assess, and prioritize the public health significance and patient risk regarding safety concerns.
• Leads and oversees development of products enforcement and compliance policy and standards; contributes to planning and development of patient-focused, risk-based compliance and enforcement strategies to secure safety, efficacy, and quality.
• Executes high-level decisions, monitors performance, and directs strategies and operations of component Offices to ensure compliance and enforcement decisions and policies are patient-focused and risk-based.
• Designs and develops internal procedures and processes to support work quality and provides oversight of implementation, monitoring, and continual improvement of the quality system.
• Develops, coordinates, and implements post-market risk assessment policies, guidance, and interpretations and, when appropriate, initiates the development or enhancement of regulations.
• Ensures that office functions and program activities are aligned to the overall strategy and priorities of CBER and FDA.
• Facilitates Super Office staff coordination between multiple, smaller program offices.
• Oversees center or office research activities, including determining if research is appropriate.
• Provides oversight for activities related to international guideline development within the Super Office to improve efficiency with the goal of reducing decision time.

Requirements

Help

Conditions of employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Males born after December 31, 1959, must be registered with the Selective Service. Please go to http://www.sss.gov for more information.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• All applicants tentatively selected for this position will be required to submit to urinalysis to screen for illegal drug use prior to appointment and be subject to random, reasonable suspicion, and post-accident drug testing upon hiring.
• Appointment to the position will be contingent upon a negative applicant drug test result.
• Probationary periods are required for new employees appointed to competitive service positions for the first time; or reinstated employees who return after a break in service of 30-days or more and who have not completed a probationary period.
• Ethics Clearance and Financial Disclosure is required.

Qualifications

In order to qualify for the Super Office Director, Office of Therapeutic Products (OTP) position which falls under the 0602 occupational Series, you must meet the following requirements by 11:59 pm EST on 08/05/2026:The candidate must meet the following qualifications for this Title 21 position:

1. Scientific, Technical, and/or Professional Fields
2. Qualified and Outstanding Candidates

a. Qualified applies to all candidates for Cures appointments. The FDA OTS will use the technical qualifications defined below as a baseline for comparing experience levels and other candidate attributes for relevant positions.

b, Outstanding candidates can be defined by existing outstanding work experience, outstanding performance rating, or both.

Technical Requirements: (Please do not submit narrative responses these qualifications must be included in your 2-page resume)

1. Experience in scientific and technical leadership, direction, and supervision to multidisciplinary scientific, engineering and medical science staff.
2. Proven ability to provide strategic scientific and technical counsel to senior leadership on complex, novel, controversial, and precedent-setting regulatory and policy issues, and to evaluate and apply regulatory requirements in support of public health decision-making.

Desired Qualifications:

1. Demonstrated expertise in cellular and gene therapies, therapeutic vaccines, plasma-derived and coagulation products, and associated medical devices, including comprehensive knowledge of FDA regulatory authorities, policies, and guidance.
2. Collaborates with other scientific, technical, and regulatory staff to develop and implement policy initiatives related to cellular, tissue gene therapy (including viral and non-viral vectors), therapeutic vaccines, and plasma-derived and coagulation products as well as associated medical devices.

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.

Supervisory Responsibilities

The incumbent is delegated full authority to achieve group goals and objectives through the effective management of available resources. Performance and accomplishments are assessed primarily through work performance indicators, staff discussion, planning sessions, review of individual project outputs, and annual program review.

Leads in a proactive, customer-responsive manner consistent with Agency vision and values, effectively communicating program issues to external audiences. Ensures financial and managerial accountability by acting with prudence when executing fiduciary responsibilities. Demonstrates high integrity and adheres to the highest ethical standards of public service. Uses effective business practices including balanced measures of results, values, and invests in each employee; emphasizes empowerment and two-way communication. Takes a leadership role in advocating for and advancing the priorities of the Agency. Serves as a role model for leadership by encouraging teamwork and a collaborative approach. Timely notifies Agency officials of all significant actions and developments, including but not limited to those related to regulatory matters, legislative matters, budget matters, reports, initiatives, and events and ensures subordinate managers do the same.

Provides reasonable accommodations needed to best utilize qualified people with disabilities.

Organizational Management:

Program Management:

Resource Management:

Personnel Performance Management:

Human Capital Management:

Ethics Clearance Requirements

This position requires financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information, please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.

All requirements must be met by the closing date of this announcement (08/05/2026); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.

Education

Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.

Education Requirements:

A degree from an accredited program or *institution in Doctor of Medicine, Doctor of Osteopathic Medicine, or equivalent. *Degree from Foreign Medical School: A Doctor of Medicine or equivalent degree from a foreign medical school must provide education and medical knowledge equivalent to accredited schools in the United States. Evidence of equivalency to accredited schools in the United States is demonstrated by permanent certification by the Educational Commission for Foreign Medical Graduates.

AND

Graduate Training: In addition to a degree, a candidate must have had at least one year of supervised experience providing direct service in a clinical

setting. For purposes of this standard, graduate training programs include only those internship, residency, and fellowship programs that are approved by accrediting bodies recognized within the US or Canada.

TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.

Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education.

If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements.

Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access.

Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation.

To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery.

Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded.

Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below:

1. National Association of Credential Evaluation Services (NACES)
2. Association of International Credentials Evaluators (AICE)

Credential evaluations are not free, and applicants are responsible for the cost of the selected service.

For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation.

Additional information

Additional Conditions of Employment:

• Pre-employment physical required: No

• Drug testing required: No

• License required: No

• Mobility agreement required: No

• Immunization required: No

• Bargaining Unit: No

• Telework eligible position: Telework is at the discretion of the supervisor.